Theraworx Relief Muscle Cramp and Spasm Relief Foam

Theraworx Relief Muscle Cramp and Spasm Relief Foam

Drug Labeling and Warnings

Drug Details

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THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF- magnesium sulfate heptahydrate aerosol, foam 
Avadim Technologies, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Theraworx Relief Muscle Cramp and Spasm Relief Foam

Drug Facts

Active Ingredient

Contains Magnesium Sulfate (Magnesia sulphurica) 6X 0.05% HPUS The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Muscle Soreness Relief

Uses

  • prevents muscle cramps
  • releases muscle tightness
  • reduces muscle soreness

Warnings

For external use only. If eye contact occurs, rinse thoroughly with water.

When using this product

avoid eye contact  do not store at temperature above 120°F  use only as directed  not for ingestion

Stop use and ask a doctor if 

unintended effects occur.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well  apply 2 pumps onto entire muscle group(s) or area  briskly rub in until absorbed   use as needed  allow to air dry

Inactive Ingredients

Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Colloidal Silver, Tocopheryl Acetate, Glycerin, Allantoin, Beta Glucan, Citrus Paradisi (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone, Methylparaben, Propylparaben, Parfum (Fragrance)

Package Labeling:

Label2

THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF 
magnesium sulfate heptahydrate aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61594-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE6 [hp_X]  in 210 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILVER (UNII: 3M4G523W1G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61594-003-00210 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/22/2017
Labeler - Avadim Technologies, Inc (041443877)
Registrant - Avadim Technologies, Inc (041443877)

Revised: 12/2017
 
Avadim Technologies, Inc


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